FDA-Device2021-02-24Class I
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.
Combat Medical Systems, LLC
Hazard
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Sold states
US Nationwide Distribution
Affected count
954 units
Manufactured in
5555 Harrisburg Ind Pk Dr, N/A, Harrisburg, NC, United States
Products
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1114-2021Don't want to check this manually?
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